ETHICAL CONSIDERATIONS REGARDING RESEARCH
WHAT ARE THE MAIN ETHICAL ISSUES IN HUMAN SUBJECTS RESEARCH?
There are several ethical issues that must be considered when designing research that will utilize participants who are human beings.
• The primary concern of the investigator should be the safety of the research participant. This is accomplished by carefully considering the risk/benefit ratio, using all available information to make an appropriate assessment and continually monitoring the research as it proceeds.
• The scientific investigator must obtain informed consent from each research participant. This should be obtained in writing (although oral consents are sometimes acceptable) after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions. Informed consent should be seen as an ongoing process, not a singular event or a mere formality.
• The investigator must enumerate how privacy and confidentiality concerns will be approached. Researchers must be sensitive to not only how information is protected from unauthorized observation, but also if and how participants are to be notified of any unforeseen findings from the research that they may or may not want to know.
• The investigator must consider how adverse events will be handled; who will provide care for a participant injured in a study and who will pay for that care are important considerations.
• In addition, before enrolling participants in an experimental trial, the investigator should be in a state of "equipoise," that is, if a new intervention is being tested against the currently accepted treatment, the investigator should be genuinely uncertain which approach is superior. In other words, a true null hypothesis should exist at the onset regarding the outcome of the trial.
WHAT ARE THE MAIN ETHICAL PRINCIPLES THAT GOVERN RESEARCH WITH HUMAN SUBJECTS?
There are three primary ethical principles that are traditionally cited when discussing ethical concerns in human subjects research.
• The first ethical principle cited as autonomy, which refers to the obligation on the part of the investigator to respect each participant as a person capable of making an informed decision regarding participation in the research study. The investigator must ensure that the participant has received a full disclosure of the nature of the study, the risks, benefits and alternatives, with an extended opportunity to ask questions. The principle of autonomy finds expression in the informed consent document.
• The second ethical principle is beneficence, which refers to the obligation on the part of the investigator to attempt to maximize benefits for the individual participant and/or society, while minimizing risk of harm to the individual. An honest and thorough risk/benefit calculation must be performed.
• The third ethical principle invoked in research with human subjects is justice, which demands equitable selection of participants, i.e., avoiding participant populations that may be unfairly coerced into participating, such as prisoners and institutionalized children. The principle of justice also requires equality in distribution of benefits and burdens among the population group(s) likely to benefit from the research.
WHAT ARE THE COMPONENTS OF AN ETHICALLY VALID INFORMED CONSENT FOR RESEARCH?
For an informed consent to be ethically valid, the following components must be present:
DISCLOSURE: The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits to the participant and/or society, the potential of reasonably foreseeable risks, stresses, and discomforts, and alternatives to participating in the research.
• There should also be a statement that describes procedures in place to ensure the confidentiality or anonymity of the participant.
• The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury.
• The document should make it clear whom to contact with questions about the research study, research subjects' rights, and in case of injury.
UNDERSTANDING: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the investigators. The informed consent document must be written in lay language, avoiding any technical jargon.
VOLUNTARINESS: The participant's consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation.
COMPETENCE: The participant must be competent to give consent. If the participant is not competent due to mental status, disease, or emergency, a designated surrogate may provide consent if it is in the participant's best interest to participate. In certain emergency cases, consent may be waived due to the lack of a competent participant and a surrogate.
CONSENT: The potential human subject must authorize his/her participation in the research study, preferably in writing, although at times an oral consent or assent may be more appropriate.
USING DECEPTION WHEN DOING RESEARCH?
• As a general rule, deception is not acceptable when doing research with humans. Using deception jeopardizes the integrity of the informed consent process and can potentially harm your participants.
• Occasionally exploring your area of interest fully may require misleading your participants about the subject of your study. For example, if you want to learn about decision-making practices of physicians without influencing their practice-style, you may consider telling them you are studying "communication behaviors" more broadly.
• The research supervisor will review any proposal that suggests using deception or misrepresentation very carefully. They will require an in-depth justification of why the deception is necessary for the study and the steps you will take to safeguard your participants.
By
RAVINDAR KUMAR
B. Arch; M. Urban Design
ASSISTANT PROFESSOR
DEPARTMENT OF ARCHITECTURE AND PLANNING
DEPARTMENT OF ARCHITECTURE AND PLANNING
NED UNIVERSITY OF ENGINEERING AND TECHNOLOGY KARACHI
INTRODUCTION:
Discussions of the ethics of research involving human beings usually center on issues regarding research design and approval and how individuals' rights and welfare are protected when they are enrolled in research protocols. The same has been true of the application of the Common Rule, which addresses only tangentially what happens after a research project has ended by requiring that research participants must be informed in advance about what benefits will be provided by the research. In recent years, however, as research sponsored by government agencies, foundations, and private companies in developed countries increasingly has been conducted in developing countries, officials in some of these countries—as well as leaders of international bodies concerned with research ethics—have begun to insist that the ethics of research address what happens when a study ends.
WHAT ARE THE MAIN ETHICAL ISSUES IN HUMAN SUBJECTS RESEARCH?
There are several ethical issues that must be considered when designing research that will utilize participants who are human beings.
• The primary concern of the investigator should be the safety of the research participant. This is accomplished by carefully considering the risk/benefit ratio, using all available information to make an appropriate assessment and continually monitoring the research as it proceeds.
• The scientific investigator must obtain informed consent from each research participant. This should be obtained in writing (although oral consents are sometimes acceptable) after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions. Informed consent should be seen as an ongoing process, not a singular event or a mere formality.
• The investigator must enumerate how privacy and confidentiality concerns will be approached. Researchers must be sensitive to not only how information is protected from unauthorized observation, but also if and how participants are to be notified of any unforeseen findings from the research that they may or may not want to know.
• The investigator must consider how adverse events will be handled; who will provide care for a participant injured in a study and who will pay for that care are important considerations.
• In addition, before enrolling participants in an experimental trial, the investigator should be in a state of "equipoise," that is, if a new intervention is being tested against the currently accepted treatment, the investigator should be genuinely uncertain which approach is superior. In other words, a true null hypothesis should exist at the onset regarding the outcome of the trial.
WHAT ARE THE MAIN ETHICAL PRINCIPLES THAT GOVERN RESEARCH WITH HUMAN SUBJECTS?
There are three primary ethical principles that are traditionally cited when discussing ethical concerns in human subjects research.
• The first ethical principle cited as autonomy, which refers to the obligation on the part of the investigator to respect each participant as a person capable of making an informed decision regarding participation in the research study. The investigator must ensure that the participant has received a full disclosure of the nature of the study, the risks, benefits and alternatives, with an extended opportunity to ask questions. The principle of autonomy finds expression in the informed consent document.
• The second ethical principle is beneficence, which refers to the obligation on the part of the investigator to attempt to maximize benefits for the individual participant and/or society, while minimizing risk of harm to the individual. An honest and thorough risk/benefit calculation must be performed.
• The third ethical principle invoked in research with human subjects is justice, which demands equitable selection of participants, i.e., avoiding participant populations that may be unfairly coerced into participating, such as prisoners and institutionalized children. The principle of justice also requires equality in distribution of benefits and burdens among the population group(s) likely to benefit from the research.
WHAT ARE THE COMPONENTS OF AN ETHICALLY VALID INFORMED CONSENT FOR RESEARCH?
For an informed consent to be ethically valid, the following components must be present:
DISCLOSURE: The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits to the participant and/or society, the potential of reasonably foreseeable risks, stresses, and discomforts, and alternatives to participating in the research.
• There should also be a statement that describes procedures in place to ensure the confidentiality or anonymity of the participant.
• The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury.
• The document should make it clear whom to contact with questions about the research study, research subjects' rights, and in case of injury.
UNDERSTANDING: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by one of the investigators. The informed consent document must be written in lay language, avoiding any technical jargon.
VOLUNTARINESS: The participant's consent to participate in the research must be voluntary, free of any coercion or promises of benefits unlikely to result from participation.
COMPETENCE: The participant must be competent to give consent. If the participant is not competent due to mental status, disease, or emergency, a designated surrogate may provide consent if it is in the participant's best interest to participate. In certain emergency cases, consent may be waived due to the lack of a competent participant and a surrogate.
CONSENT: The potential human subject must authorize his/her participation in the research study, preferably in writing, although at times an oral consent or assent may be more appropriate.
USING DECEPTION WHEN DOING RESEARCH?
• As a general rule, deception is not acceptable when doing research with humans. Using deception jeopardizes the integrity of the informed consent process and can potentially harm your participants.
• Occasionally exploring your area of interest fully may require misleading your participants about the subject of your study. For example, if you want to learn about decision-making practices of physicians without influencing their practice-style, you may consider telling them you are studying "communication behaviors" more broadly.
• The research supervisor will review any proposal that suggests using deception or misrepresentation very carefully. They will require an in-depth justification of why the deception is necessary for the study and the steps you will take to safeguard your participants.
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